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medicationThe FDA has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards.  Other sites received regulatory warnings.

While the prices look good, you never really know what you’re getting.  These products can have too much or too little of the active ingredient that people need for the treatment of their disease, and some could have toxic ingredients.  Several of the sites had sleek interfaces and names that could easily be confused with legitimate pharmacies.  Walgreens-Store.com for example – the drugstore chain is actually Walgreens.com.

Though many of the sites present themselves as Canadian, most of them are based overseas – China, India, Pakistan, all around the world.  The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites and found that 97% did not fully comply with state and federal regulations. 88% didn’t require a valid prescription, and almost half of them sold medicines lacking FDA approval.

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painA Georgia federal jury ruled for the Defendant this week, determining that Mentor Worldwide LLC was not negligent in its design, manufacture, and sale of the ObTape pelvic mesh.

Also known as a vaginal sling, Plaintiff was implanted with the ObTape in December 2004 to treat bladder prolapse and urinary incontinence.  Six months later, she was diagnosed with vaginitis and a doctor found that the mesh had extruded into her vagina.

She filed suit claiming that the ObTape caused vaginal erosion and required surgical removal.  She further claimed that the pore size of the ObTape was insufficient to allow for tissue to become integrated into the device.  She said the mesh created a propensity for infection and/or abscess, resulting in an unreasonably high rate of infection, abscesses, tissue erosion and mesh extrusion.

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May brought changes to forty (40) medical product labels (down from 48 changes in April), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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A recall of one lot of Advance Pharmaceutical’s 81mg Enteric Coated Aspirin tables is being recalled as it may contain Acetaminophen 500mg tablets.

Affected by this recall is the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tables, 81 mg, Lot 13A026.  Packaged in bottles of 120 tables, the NDC code is 0536-3086-41, UPC code is 3 0536-3086-41 9, and the expiration date of 01-2015.

The recall was announced after a complaint of the error was reported.  Consumers may be inadvertently taking Acetaminophen instead of Aspirin, which may cause severe liver damage to those who take other drugs containing acetaminophen.

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davinciThis week, a Washington state court granted the first verdict for a slew of cases concerning the da Vinci Surgical System robots. The jury found that the robot’s creators, Intuitive Surgical, was not liable for the death of a surgery patient who succumbed to complications of a robot assisted prostatectomy. These robots, part of a $2.2 billion dollar industry, have allegedly resulted in patient injury and death. This case was the first of approximately thirty that are currently working their way through the courts with many, many more sitting on the sidelines that may settle before suit is ever filed.

The plaintiff settled for an undisclosed amount with his doctor, and then sued Intuitive Surgical. Plaintiffs alleged that Intuitive failed to properly instruct the robot’s handler, and that they also failed to inform of the potential dangers. The doctor, who had performed a hundred successful traditional prostatectomies, was only trained for a single day and performed two supervised surgeries before being cleared to work on his own.  Let’s put it this way: would you ever allow this doctor to use the da Vinci on you if you knew that?  The answer?  Of course not.

Intuitive agreed with the plaintiffs on the doctor’s negligence and claimed he never should have used the da Vinci system on the particular patient due to his obesity.

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Last month we told you that a group of Plaintiffs had filed a motion to consolidate all federal Lipitor diabetes lawsuits before one South Carolina judge as part of a Multi-District Litigation or MDL.  To date, at least five different Lipitor lawsuits have been filed against Pfizer in three different U.S. District Courts throughout the country. The motion indicates that numerous additional complaints are expected.

lipitorNot surprising, Pfizer has indicated that they are opposed to the formation of coordinated proceedings involving Lipitor, arguing that the litigation is not sufficient big enough to require the consolidated proceedings and that such a procedure would only result in a wave of lawsuits filed by lawyers who may not otherwise be willing to litigate claims.

Lipitor has been linked to diabetes. Lipitor prevents an enzyme in the liver from creating low density lipids (LDLs).  The drug works to prevent the production of LDLs, a type of cholesterol that blocks arteries, and reduce the user’s risk of developing heart disease. Lipitor, which generates more than $14.5 billion in combined annual sales, is among the best selling drugs in the world.

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Five plaintiffs last week sought an MDL for federal lawsuits against Pfizer’s Lipitor.  The allegations are the same in all cases: the cholesterol drug caused them to develop diabetes.

The gist of plaintiffs claims is that the drug increased serum glucose levels causing diabetes.  Pfizer never properly let patients or doctors know of this risk so they could make a different choice or perhaps avoid this class of drugs all together. Accordingly, the suits allege, Lipitor is defective and unreasonably dangerous and the drug was sold with a warning that did not properly alert patients and doctors of the risk.

Not for nothing, Pfizer has been making money had over fist with Pfizer.  If you have help Pfizer stock in the last few years, you have gotten pretty rich in no small part due to Lipitor.

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Last month brought changes to fifty-three (53) medical product labels (way up from 35 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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mirenaiudlawsuitMuch to the objection of Bayer Healthcare, Mirena IUD lawsuits at the federal level have been centralized into a multidistrict litigation, or MDL. The cases will be transferred to a U.S. District Court Judge in the Southern District of New York.  This makes the claim a mini-class action.  What does this mean?  The Mirena lawsuits are consolidated for discovery purposes.  They become one class case for a while.  If a global settlement of these Mirena lawsuits cannot be achieved, they will be sent back to their individual states for trial.

Last week, we told you that similar consolidation was being reconsidered at the state level, where more than 60 Mirena IUD lawsuits are currently pending.  Currently, there are only about 40 lawsuits in federal court, however it is anticipated by some plaintiffs’ attorneys that several thousand cases will be filed by women who have experienced complications from Mirena IUD.

If you used Mirena and experienced complications, including surgical removal, infection, or Pelvic Inflammatory Disease (PID) and want to inquire as to whether you have a lawsuit, contact our Mirena defect lawyers at 1.800.553.8082, or online here.

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The FDA proposed last month that makers of automated external defibrillators (AEDs) be  required to submit premarket approval (PMA) applications for these devices.  Why?  They have receive 45,000 reports – not a typo – of failures of these devices in the last 8 years.  My gosh, I’m surprised they are so ubiquitous that they even have been used 45,000 times.

But these things – these literally life and death machines – have had 8 recalls in the last eight years.  Pathetic.  The problems usually involve the AEDs powering off during use, error messages caused by software anomalies or just component failure.

I don’t trust these things. Yet I still dutifully carry one on the court when I play tennis with my father.  Can you imagine the horror of needing to use one of these things and you are getting an error message?